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Start Over Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Copyright Public domain ✖Remove constraint Copyright: Public domain Publication Year 2020 to 2021 ✖Remove constraint Publication Year: <span class="from" data-blrl-begin="2020">2020</span> to <span class="to" data-blrl-end="2021">2021</span>

101. Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):
Drug Development -- standards
Drugs, Investigational
Rare Diseases -- drug therapy
Metabolism, Inborn Errors -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

103. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

105. Enforcement policy for sterilizers, disinfectant devices, and air purifiers during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 2020
Subject(s):
Air Filters
Coronavirus Infections -- epidemiology
Disinfection -- instrumentation
Pandemics
Sterilization -- instrumentation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

106. Enforcement policy for gowns, other apparel, and gloves during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Personal Protective Equipment -- supply & distribution
Surgical Attire -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

107. Enforcement policy for ventilators and accessories and other respiratory devices during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Center for Devices and Radiological Health, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Ventilators, Mechanical -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

108. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

109. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization

Publication:
Silver Spring, MD : Center for Tobacco Products, January 2020
Subject(s):
Commerce -- legislation & jurisprudence
Electronic Nicotine Delivery Systems -- standards
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- standards
Adolescent
Government Regulation
Product Labeling
Vaping -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.